Tranexamic Acid After Aneurysmal Subarachnoid Hemorrhage Post Hoc Analysis of the ULTRA Trial

被引：6

作者：

Tjerkstra, Maud A. ^{[1
]}

Post, Rene ^{[1
]}

Germans, Menno R. ^{[2
]}

Vergouwen, Mervyn D. I. ^{[3
]}

Jellema, Korne ^{[4
]}

Koot, Radboud W. ^{[5
]}

Kruyt, Nyika D. ^{[6
]}

Willems, Peter W. A. ^{[3
]}

Wolfs, Jasper F. C. ^{[7
]}

de Beer, Frits C. ^{[8
]}

Kieft, Hans ^{[9
]}

Nanda, Dharmin ^{[8
]}

van der Pol, Bram ^{[10
]}

Roks, Gerwin ^{[11
]}

de Beer, Frank ^{[12
]}

Halkes, Patricia H. A. ^{[13
]}

Reichman, Loes J. A. ^{[14
]}

Brouwers, Paul J. A. M. ^{[15
]}

van den Berg-vos, Renske M. ^{[16
,17
]}

Kwa, Vincent I. H. ^{[16
]}

van der Ree, Taco C. ^{[18
]}

Bronner, Irene ^{[19
]}

Bienfait, Henri P. ^{[20
]}

Boogaarts, Hieronymus ^{[21
]}

Klijn, Catharina J. M. ^{[22
]}

van den Berg, Rene ^{[23
]}

Coert, Bert A. ^{[1
]}

Horn, Janneke ^{[24
]}

Majoie, Charles B. L. M. ^{[23
]}

Rinkel, Gabriel J. E. ^{[3
]}

Roos, Yvo B. W. M. ^{[17
]}

Vandertop, W. Peter ^{[1
]}

Verbaan, Dagmar ^{[1
]}

机构：

[1] Amsterdam Univ Med Ctr, Amsterdam Neurosci Res Inst, Dept Neurosurg, Amsterdam, Netherlands

[2] Univ Hosp Zurich, Clin Neurosci Ctr, Dept Neurosurg, Zurich, Switzerland

[3] Univ Utrecht, Univ Med Ctr Utrecht, UMC Utrecht Brain Ctr, Dept Neurol & Neurosurg, Utrecht, Netherlands

[4] Haaglanden Med Ctr, Dept Neurol, The Hague, Netherlands

[5] Leids Univ, Med Ctr, Dept Neurosurg, Leiden, Netherlands

[6] Leids Univ, Med Ctr, Dept Neurol, Leiden, Netherlands

[7] Haaglanden Med Ctr, Dept Neurosurg, The Hague, Netherlands

[8] Isala Hosp, Dept Neurosurg, Zwolle, Netherlands

[9] Isala Hosp, Dept Intens Care, Zwolle, Netherlands

[10] Elisabeth Tweesteden Ziekenhuis, Dept Neurosurg, Tilburg, Netherlands

[11] Elisabeth Tweesteden Ziekenhuis, Dept Neurol, Tilburg, Netherlands

[12] Spaarne Gasthuis, Dept Neurol, Haarlem, Netherlands

[13] Noordwest Ziekenhuisgrp, Dept Neurol, Alkmaar, Netherlands

[14] Ziekenhuisgrp Twente, Dept Neurol, Almelo, Netherlands

[15] Med Spectrum Twente, Dept Neurol, Enschede, Netherlands

[16] OLVG, Dept Neurol, Amsterdam, Netherlands

[17] Univ Amsterdam, Med Ctr, Llocat AMC, Dept Neurol, Amsterdam, Netherlands

[18] Dijklander Hosp, Dept Neurol, Hoorn, Netherlands

[19] Flevo Hosp, Dept Neurol, Almere, Netherlands

[20] Gelre Hosp, Dept Neurol, Apeldoorn, Netherlands

[21] Radboud Univ Nijmegen, Med Ctr, Dept Neurosurg, Nijmegen, Netherlands

[22] Radboud Univ Nijmegen, Med Ctr, Donders Inst Brain Cognit & Behav, Dept Neurol, Nijmegen, Netherlands

[23] Univ Amsterdam, Med Ctr, Locat AMC, Dept Radiol & Nucl Med, Amsterdam, Netherlands

[24] Univ Amsterdam, Med Ctr, Locat AMC, Dept Intens Care, Amsterdam, Netherlands

来源：

NEUROLOGY | 2022年 / 99卷 / 23期

关键词：

ANTIFIBRINOLYTIC TREATMENT; INTRACRANIAL ANEURYSMS; MANAGEMENT; BENEFITS; THERAPY; STROKE;

D O I：

10.1212/WNL.0000000000201160

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Background and Objectives The ULTRA trial showed that ultra-early and short-term tranexamic acid treatment after subarachnoid hemorrhage did not improve clinical outcome at 6 months. An expected proportion of the included patients experienced nonaneurysmal subarachnoid hemorrhage. In this post hoc study, we will investigate whether ultra-early and short-term tranexamic acid treatment in patients with aneurysmal subarachnoid hemorrhage improves clinical outcome at 6 months.Methods The ULTRA trial is a multicenter, prospective, randomized, controlled, open-label trial with blinded outcome assessment, conducted between July 24, 2013, and January 20, 2020. After confirmation of subarachnoid hemorrhage on noncontrast CT, patients were allocated to either ultra-early and short-term tranexamic acid treatment with usual care or usual care only. In this post hoc analysis, we included all ULTRA participants with a confirmed aneurysm on CT angiography and/or digital subtraction angiography. The primary endpoint was clinical outcome at 6 months, assessed by the modified Rankin scale (mRS), dichotomized into good (0-3) and poor (4-6) outcomes.Results Of the 813 ULTRA trial patients who experienced an aneurysmal subarachnoid hemorrhage, 409 (50%) were assigned to the tranexamic acid group and 404 (50%) to the control group. In the intention-to-treat analysis, 233 of 405 (58%) patients in the tranexamic acid group and 238 of 399 (60%) patients in the control group had a good clinical outcome (adjusted odds ratio [aOR] 0.92; 95% CI 0.69-1.24). None of the secondary outcomes showed significant differences between the treatment groups: excellent clinical outcome (mRS 0-2) (aOR 0.76; 95% CI 0.57-1.03), all-cause mortality at 30 days (aOR 0.91; 95% CI 0.65-1.28), and all-cause mortality at 6 months (aOR 1.10; 95% CI 0.80-1.52).Discussion Ultra-early and short-term tranexamic acid treatment did not improve clinical outcomes at 6 months in patients with aneurysmal subarachnoid hemorrhage and therefore cannot be recommended.Classification of Evidence This study provides Class II evidence that tranexamic acid does not improve outcomes in patients presenting with aneurysmal subarachnoid hemorrhage.

引用

页码：E2605 / E2614

页数：10

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[1] Tranexamic acid for aneurysmal subarachnoid hemorrhage
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Boet, Ronald
Gin, Tony
Ng, Stephanie C. P.
Zee, Benny C. Y.
[J]. STROKE, 2010, 41 (08) : 1841 - 1844
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HASAN, D
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FORSSELL, A
LILIEQUIST, B
SCHANNONG, M
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Verbaan, Dagmar
[J]. LANCET, 2021, 397 (10269): : 112 - 118

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